Clinical trial · Interventional
EO2 Oxygen Delivery To Study Success Rate of Surgically Closed Wounds
Evaluation of Oxygen Delivery With TransCu O2 to Study Success Rate of Surgically Closed Wounds
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators will test the efficacy of the novel oxygen diffusion dressing allows delivery tissue oxygenation via TransCu O2® Oxygen Delivery System for use in caring for patients with surgically closed wounds. The investigators hypothesize that using this novel oxygen diffusion dressing will reduce the likelihood of necrotic tissue as well as severe incisional scar post-surgical closure by improving transcutaneous oxygen levels during wound healing process. TransCu O2 Oxygen Delivery System is a novel wound healing therapy that promises to enhance tissue hydration, which in turn may lead to quick epithelialization essential to reduce the likelihood of formation of necrotic tissue and excessive scars.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Amputation Wound | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Diabetes | — | UNRESOLVED | — |
| Diabetic Foot | — | UNRESOLVED | — |
| Incision Wound | — | UNRESOLVED | — |
| Peripheral Arterial Disease | — | UNRESOLVED | — |
| Surgical Wound | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transcu O2® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Active
- description
- Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care.
- interventionNames
- Device: Transcu O2®
- type
- NO_INTERVENTION
- label
- Control
- description
- Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks.
Primary outcomes (1)
- measure
- Number of Participants With Unfavorable Wound Healing Outcomes at 4 Weeks
- timeFrame
- 4 weeks
- description
- Unfavorable wound healing outcomes were defined as the occurrence of one or more of the following conditions : infection, wound dehiscence, or necrotic tissue, as documented in the patient chart up to 4 weeks after the surgical wound closure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * 18-85 years of age. Ability to provide informed consent. * Presence of a wound due to surgical intervention and closure. * Subject or responsible caregiver is willing and able to maintain the required offloading (as applicable for the location of the wound) and applicable dressing changes Exclusion Criteria: * Charcot Arthropathy Bilateral AK/BK amputation Active Drug/alcohol abuse (or history of drug/alcohol abuse in last 1 month) Dementia or impaired cognitive function Subjects with osteomyelitis or extreme gangrene. Excessive lymphedema Presence of active infection Subject has a history of or any intercurrent illnesses or conditions that would compromise the safety of the subject according to judgement of a qualified wound specialist.
References
Publications (0)
Data not yet available